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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-J2000-08

Original Effective Date: 3/15/14

Reviewed: 11/09/16

Revised: 12/15/16

Subject: Temsirolimus (Torisel®) Injection

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Dosage/ Administration Position Statement Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates  
           

DESCRIPTION:

Temsirolimus (Torisel®) is an inhibitor of mammalian target of rapamycin (mTOR) and is Food and Drug Administration (FDA)-approved for the treatment of renal cell carcinoma. National Comprehensive Cancer Network (NCCN) Kidney Cancer Guidelines recommend temsirolimus as a first-line option for relapsed or medically unresectable advanced (Stage IV) disease or as subsequent therapy in patients with predominant clear cell histology. NCCN guidelines also recommend temsirolimus for relapsed or medically unresectable advanced (Stage IV) disease with non-clear cell histology. Temsirolimus is also recommended by NCCN for certain types of soft tissue sarcoma and uterine carcinomas.

POSITION STATEMENT:

Initiation of temsirolimus (Torisel®) meets the definition of medical necessity when used for an indication in Table 1 and all of the indication specific criteria are met:

Table 1

Indication

Specific Criteria

Kidney cancer

When ALL of the following are met:

1. Member is diagnosed with relapsed or surgically unresectable stage IV disease

2. Temsirolimus will be used as a single agent

3. The dose does not exceed 25 mg weekly*

4. EITHER of the following

a. Temsirolimus is used as first line or subsequent therapy for disease with predominant clear cell histology

b. Temsirolimus is used for treatment of disease with non-clear cell histology

Soft-tissue sarcoma (STS)

When used as a single agent and the dose does not exceed 25 mg weekly in members diagnosed with ONE of the following:

1. Perivascular epithelioid cell tumor(s) (PEComa)

2. Recurrent angiomyolipoma

3. Recurrent lymphangioleiomyomatosis

Uterine cancer (endometrial carcinoma)

When used as a single agent and the dose does not exceed 25 mg weekly for ONE of the following:

1. Primary treatment for extrauterine disease with endometriod histology (e.g., abdominal, pelvic, extra-abdominal, liver, etc.)

2. In combination with radiation therapy for disease unsuitable for primary surgery with endometrioid histology and cervical involvement

3. Member has stage III or IV disease

4. Member has disseminated metastases

5. Member has local/regional recurrence

6. Member has serous carcinoma, clear cell carcinoma, or carcinosarcoma of the endometrium and stage I-IV disease

Approval duration: 180 days

Continuation of temsirolimus (Torisel®) meets the definition of medical necessity when used as a single agent for the indications in Table 1 and the following criteria are met:

A. The member’s disease has not progressed while receiving therapy with temsirolimus

B. The member has been previously approved by Florida Blue or another health plan in the past 2 years, OR the member has previously met all indication-specific criteria for coverage

C. The dose does not exceed 25 mg weekly*

Approval duration: 1 year

*NOTE: Avoid use with strong CYP3A4 inhibitors or inducers. If coadministration of a strong CYP3A4 inducer (e.g., carbamazepine, dexamethasone, phenobarbital, phenytoin, rifabutin, rifampacin, rifampin) cannot be avoided, a dose greater than 25 mg weekly will be permitted for FDA-approved indications. Per FDA-labeling, the dose may need to be increased to 50 mg/week in patients receiving strong CYP3A4 inducers receiving therapy for renal cell carcinoma. A dose reduction should be considered if coadministration with strong CYP3A4 inhibitors cannot be avoided.

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

FDA-approved: temsirolimus is indicated for the treatment of advanced renal cell carcinoma. The recommended dose is 25 mg infused over 30-60 minutes once a week. Therapy should be continued until disease progression or toxicity. Individuals should receive anti-histamine pre-medication.

Dose Adjustments:

Adverse reactions: interrupt therapy for absolute neutrophil count (ANC) <1000/mm3, platelet count <75,000/mm3, or adverse events of grade 3 or greater according to the Common Terminology Criteria for Adverse Events (CTCAE). Once toxicity has resolved to grade 2 or less, temsirolimus may be restarted with the dose reduced by 5 mg/week to a dose no lower than 15 mg/week.

Hepatic impairment: use caution when treating individuals with mild hepatic impairment. If temsirolimus must be given to an individual with mild hepatic impairment, reduce the dose to 15 mg/week.

Drug interactions: avoid use with strong CYP3A4 inhibitors or inducers. If use cannot be avoided, see prescribing information for dose recommendations.

Drug Availability: temsirolimus is supplied as a 25 mg/mL

PRECAUTIONS:

Contraindications: temsirolimus is contraindicated in persons with a bilirubin greater than 1.5 times the upper limit of normal

Precautions/Warnings

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding:

J9330

Injection, temsirolimus, 1 mg

ICD-10 Diagnoses Codes That Support Medical Necessity: (Effective 10/01/15)

C49.0 – C49.9

Malignant neoplasm of connective and soft tissue

C54.1

Malignant neoplasm of endometrium

C54.2

Malignant neoplasm of myometrium

C54.3

Malignant neoplasm of fundus uteri

C54.9

Malignant neoplasm of corpus uteri, unspecified

C64.1 – C64.9

Malignant neoplasm of unspecified kidney, except renal pelvis

C65.1 – C65.9

Malignant neoplasm of unspecified renal pelvis

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Part D: BCBSF has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

Medicare Advantage: No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline revised date.

DEFINITIONS:

None

RELATED GUIDELINES:

Bevacizumab (Avastin) Injection, 09-J0000-66
Pazopanib (Votrient™) Tablets, 09-J1000-49

Sorafenib (Nexavar®) Tablets, 09-J1000-50

Sunitinib (Sutent) Capsules, 09-J1000-51

OTHER:

Table 1: Common Terminology Criteria for Adverse Events v4.0 (CTCAE)

Grade

Description

1

Mild; asymptomatic or mild symptoms; clinical diagnostic observations only; intervention not indicated

2

Moderate; minimal, local or noninvasive intervention indicated; limited age-appropriate instrumental activities of daily living

3

Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living

4

Life-threatening consequences; urgent intervention indicated

5

Death related to adverse event

REFERENCES:

  1. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2016. URL www.clinicalpharmacilogy-ip.com Accessed 10/20/16.
  2. Hess G, Herbrecht R, Romaguera J et al. Phase III study to evaluate temsirolimus compared with investigator’s choice therapy for the treatment of relapsed or refractory mantle cell lymphoma. J Clin Oncol. 2009; 27: 3822-3829
  3. Ingenix HCPCS Level II, Expert 2013.
  4. Ingenix ICD-9-CM for Physicians-Volumes 1 & 2, Expert 2013
  5. Micromedex® Healthcare Series [Internet Database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed 10/20/16.
  6. National Comprehensive Cancer Network. Cancer Guidelines. Cancer Guidelines and Drugs and Biologics Compendium. Accessed 10/20/16.
  7. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 1.2017 Kidney Cancer. Available at http://www.nccn.org/professionals/physician_gls/PDF/kidney.pdf Accessed 10/20/16.
  8. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 3.2016 Non-Hodgkin’s Lymphomas. Available at http://www.nccn.org/professionals/physician_gls/PDF/nhl.pdf Accessed 10/25/16.
  9. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 2.2016 Soft tissue sarcoma. Available at http://www.nccn.org/professionals/physician_gls/PDF/sarcoma.pdf Accessed 10/24/16.
  10. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 2.2016 Uterine Cancer. Available at http://www.nccn.org/professionals/physician_gls/PDF/uterine.pdf Accessed 10/24/16.
  11. Temsirolimus. In McEvoy GK, editor. AHFS drug information 2016 [monograph on the internet]. Bethesda (MD): American Society of Health-System Pharmacists; 2016 [cited 2016 Oct 20]. Available from http://online.statref.com Subscription required to review
  12. Torisel® (Temsirolimus) [package insert]. Wyeth Pharmaceuticals Inc. Philadelphia (PA): July 2016

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 11/09/16.

GUIDELINE UPDATE INFORMATION:

3/15/2014

New Medical Coverage Guideline.

12/15/15

Review and revision to guideline; consisting of updating position statement, description, dosage, coding and references.

12/15/16

Review and revision to guideline; consisting of updating position statement, description, coding and references.

Date Printed: October 23, 2017: 02:15 AM